Introduzione

The EudraVigilance Data Analysis System (EVDAS) launched in 2018 represents a new and very important source for signal detection and signal evaluation in Europe by providing Marketing Authorisation Holders (MAH) access to one of the biggest pharmacovigilance database in the world. According to the Guidelines on Good Pharmacovigilance Practices (GVP) and other regulatory documents, EMA demands the obligatory use of this system for the evaluation of signals detected via other sources than EVDAS (so called external signals) and partly also for signal detection. Furthermore, EVDAS as additional source of information is intended to widen the MAH’s continuous benefit risk assessment of medicinal products. However, the new responsibilities like monitoring obligations as well as handling complex data sets, represent major challenges. Especially small and medium-sized enterprises (SMEs) are burdened with the heavy workload associated with the collection, review and assessment of the provided information. Therefore, it is crucial to find an approach to select the relevant information avoiding unnecessary steps. This online training course will provide a clear overview on different types of reports that can be retrieved from EVDAS as well as the use of the database regarding different aspects of signal management. Practical tips on analysis of EVDAS outputs (eRMRs & line listings) will be also provided within an interactive session during which the attendees will have the opportunity to ask questions.

The online training course will be subdivided in 2 modules and cover the following aspects:

  • Using EVDAS in signal management systems for signal detection and signal evaluation
  • EudraVigilance access policy and recent updates of the EudraVigilance system
  • Introduction of EVDAS and its 3 report types
  • Strategy to analyse eRMRs and line listings retrieved from EVDAS

Details on the modules are provided underneath – the training course can be subdivided in two 2 hours modules (Modules 1 and 2).

Module 1

The use of EVDAS: how to use EVDAS in the signal management system?

In particular:

  • the use of EVDAS to evaluate (validated) signals identified via other sources than EVDAS (i.e. literature search, database, ICSRs, etc.)
  • the use of EVDAS for signal detection
  • the implementation of EVDAS data in PSURs

Introduction to EVDAS and on the information that can be retrieved from the database: Active substance grouping, eRMR, Line listing,

What these reports are and why we need them

 

Module 2

  • Different strategies to analyse the information retrieved via EVDAS
  • How to identify potential risks via EVDAS – tips to define your parameters to select relevant information.
  • How to analyse a line listing, what it is needed to be taken into account and few tips to make the analysis smooth.

 

Interactive discussions with participants are desired during the online course to share experiences in the daily activities and potential issues/concerns occurring while using EVDAS. A few weeks before starting this training, participants can send specific questions regarding the different aspects proposed in the program in order to productively answer those topics within the webinar. In addition, exercises will be provided to allow participants to put in practice what has been discussed.

This online training targets any person working in pharmacovigilance and who is interested in the use of EVDAS and its application in a signal management system: Qualified Person for Pharmacovigilance (QPPV), Pharmacovigilance Assistants, Advisors and Managers, EudraVigilance Users, Pharmacovigilance Auditors, Professionals belonging to Pharmaceutical Companies, Service Providers (CRO, CSO, Consultants), Biotech Companies and any MAH interested in understanding the role of EVDAS and its use.

This course aimed to provide an overview of what EVDAS can offer and its use in MAH‘s signal management system. Tips and analytical methods will be discussed during this course.

Participant experience

The training is recommended for those who know the Good Pharmacovigilance Practices (GVP) reference (Form VI, V and IX) and having at least 6 months of pharmacovigilance experience.

The online training will be prepared to be interactive and will present both theoretical but also practical aspects of EVDAS. During the different sessions, EVDAS dashboard will be used to allow a true discovery of what EVDAS can offer. Some tips regarding EVDAS data analysis will be also provided.

Docente/i
Harmonie Etienne
Info

Harmonie Etienne

Homecare Trial Coordinator, Emovis GmbH
Harmonie completed her studies in biochemistry, molecular & cell biology and molecular physiopathology. She then did 3 years of research in academics before following a training in Clinical Research. She worked in a biotech company in both Clinical Operation and PV Departments. The last two years, Harmonie worked in the medical science and PV department of Dr. Ebeling & Assoc. GmbH – an experienced pharma consultancy in January 2019. She became Leader of the EV-based Signal Management (EViSiMa®) project and her goal was to continuously improve the system to ensure compliance with EMA´s requests by proposing an efficient/optimized approach to detect, validate and further assess signals via EVDAS. Since September 2020, Harmonie works as a Homecare Trial Coordinator at Emovis GmbH.

Online Training – 2 modules

MODULE 1 | 07 April 2021 from10:30 am to 12:30 pm CEST

MODULE 2 | 09 April 2021 from10:30 am to 12:30 pm CEST

 

After the registration, you will receive all details about the connection.

 

The course admits maximum 12 attendees.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 460,00* (until 10 March 2021)

Ordinary: € 540,00*

Freelance – Academy – Public Administration**: € 275,00*

* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.


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Risultato atteso
The audience will be able to define the new responsibilities associated with the EudraVigilance Data Analysis System (EVDAS).
Risultato atteso
The participants will be qualified to differentiate significant information from the complex datasets provided by EVDAS and find pragmatic solutions for the monitoring of the new system.